[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560828":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":42,"responsibleParty":104,"collaborators":106,"id":114,"slug":115,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":25,"eligibilityCriteria":120,"healthyVolunteers":116,"sex":121,"minAge":122,"maxAge":123,"enrollmentInfo":124,"targetDuration":25,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":134,"overallStatus":45,"whyStopped":25,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"Karolinska Institutet","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Internet-delivered exposure and response prevention (I-ERP)","EXPERIMENTAL","A therapist-guided, internet-delivered exposure and response prevention (I-ERP) programme for children and adolescents with OCD and autism.",[13],"Behavioral: Internet-delivered exposure and response prevention (I-ERP)",{"label":15,"type":16,"description":17,"interventionNames":18},"Internet-delivered stress management (I-SM)","ACTIVE_COMPARATOR","A therapist-guided, internet-delivered stress management (I-SM) programme for children and adolescents with OCD and autism.",[19],"Behavioral: Internet-delivered stress management (I-SM)",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","The intervention is internet-delivered and therapist-guided, involving the child and at least one caregiver. It consists of two separate sets of modules, one for the child and one for the caregiver. The intervention consists of 12 modules, delivered over a maximum of 14 weeks.\n\nThe treatment includes psychoeducation about ASD, OCD, emotions, healthy habits, the difference between repetitive behaviours in autism and OCD, how compulsions maintain the obsessions, and the rationale for ERP. The main focus of the treatment is ERP tasks based on the young person's individual goals. The modules also contain homework tasks that are meant to be completed between modules, mainly consisting of ERP. The final module includes a summary of the treatment and a relapse prevention plan.\n\nThe version for parents consists of the same content as the child treatment, but with elaborated psychoeducation, and additional focus on strategies on how to assist their child in the different exposure tasks.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"The intervention is internet-delivered and therapist-guided, involving the child and at least one caregiver. It consists of two separate sets of modules, one for the child and one for the caregiver. The intervention consists of 12 modules, delivered over a maximum of 14 weeks.\n\nThe treatment includes psychoeducation about ASD, OCD, healthy habits, and how stress is a contributor to OCD symptoms. The rationale is that targeting and reducing stress will have a beneficial impact on anxiety, obsessions, and compulsions. The main goal of the treatment is to learn how to reduce stress, mainly by using relaxation techniques such as deep breathing, progressive muscle relaxation, and imagery (cognitive) relaxation. The modules also contain homework tasks that are meant to be completed between modules, mainly consisting of relaxation tasks.\n\nThe version for parents contains psychoeducation, as well as strategies on how to assist their child in the different relaxation tasks.",[15],[30],{"name":31,"affiliation":5,"role":32},"David Mataix-Cols","PRINCIPAL_INVESTIGATOR",[34,38],{"name":31,"role":35,"phone":36,"phoneExt":25,"email":37},"CONTACT","+46723986889","david.mataix.cols@ki.se",{"name":39,"role":35,"phone":40,"phoneExt":25,"email":41},"Moa Warnström","+46768419808","moa.warnstrom@ki.se",[43,67,85],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Forskningsmottagning barn- och ungdomspsykiatri Lund","RECRUITING","Lund","Skåne County","222 41","Sweden","SE",{"type":52,"coordinates":53},"Point",[54,55],13.19321,55.70584,{"lat":55,"lon":54},[58,62,65],{"name":59,"role":35,"phone":60,"phoneExt":25,"email":61},"Per Andrén, PhD","+4670-435 17 40","per.andren@med.lu.se",{"name":63,"role":35,"phone":25,"phoneExt":25,"email":64},"Hilma Carlsson, MSc","hilma.carlsson@skane.se",{"name":66,"role":32,"phone":25,"phoneExt":25,"email":25},"Eva Serlachius, Professor",{"facility":68,"status":45,"city":69,"state":70,"zip":71,"country":49,"countryCode":50,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Child and Adolescent Psychiatry Research Center","Stockholm","Stockholm County","113 30",{"type":52,"coordinates":73},[74,75],18.06871,59.32938,{"lat":75,"lon":74},[78,81,84],{"name":79,"role":35,"phone":80,"phoneExt":25,"email":37},"David Mataix-Cols, Professor","+46 723986889",{"name":82,"role":35,"phone":83,"phoneExt":25,"email":41},"Moa Warnström, MSc","+46 812352591",{"name":79,"role":32,"phone":25,"phoneExt":25,"email":25},{"facility":86,"status":45,"city":87,"state":88,"zip":89,"country":49,"countryCode":50,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"BUP Specialmottagning","Gothenburg","Västra Götalandsregionen","411 14",{"type":52,"coordinates":91},[92,93],11.96679,57.70716,{"lat":93,"lon":92},[96,100,103],{"name":97,"role":35,"phone":98,"phoneExt":25,"email":99},"Karin Melin, PhD","+4673-049 43 48","karin.a.melin@vgregion.se",{"name":101,"role":35,"phone":25,"phoneExt":25,"email":102},"Lisa Norlin, MSc","lisa.norlin@vgregion.se",{"name":97,"role":32,"phone":25,"phoneExt":25,"email":25},{"type":32,"investigatorFullName":31,"investigatorTitle":105,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Principal Investigator",[107,110,112],{"name":108,"class":109},"Region Stockholm","OTHER_GOV",{"name":111,"class":6},"Region Skane",{"name":113,"class":109},"Vastra Gotaland Region","100560828","icbt-for-ocd-in-children-with-autism-100560828",false,"NCT06582225","ICBT for OCD in Children With Autism","Internet-delivered Cognitive-behaviour Therapy for Obsessive- Compulsive Disorder in Children With Autism: A Randomised Controlled Trial","Inclusion Criteria:\n\n1. A diagnosis of autism, based on the diagnostic criteria of the 4th or 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM) or the 10th edition of the International Classification of Diseases (ICD-10). Informed by the parent\u002Fcaregiver and subsequently confirmed by review of the medical record or the neurodevelopmental assessment report. A diagnosis of autism will be considered present if it was established with validated instruments, such as the Autism Diagnostic Interview-Revised (ADI-R), the Autism Diagnostic Observation Schedule (ADOS) edition 1 or 2 or the Diagnostic Interview for Social and Communication Disorders (DISCO; autism or ASD cut-offs).\n2. A DSM-5 diagnosis of OCD. Confirmed by the assessor at the inclusion assessment, based on a structured diagnostic interview.\n3. A total score of ≥16 on the CY-BOCS. Confirmed by the assessor at the inclusion assessment.\n4. Age between 7 and 17 years. Confirmed by the caregiver and subsequently by the medical record system.\n5. Ability to read and write Swedish. Confirmed by the caregiver at the telephone screening or\u002Fand the inclusion assessment.\n6. Regular access to a computer or a smartphone\u002Ftablet connected to the internet, and a mobile phone to receive text messages. Confirmed by the caregiver at the telephone screening or\u002Fand inclusion assessment.\n7. A parent\u002Fcaregiver able to participate in the treatment alongside their child. Confirmed by the caregiver at the telephone screening or\u002Fand the inclusion assessment.\n\nExclusion Criteria:\n\n1. Global intellectual disability. Informed by the parent\u002Fcaregiver and subsequently confirmed by review of the medical record or the neurodevelopmental assessment report, and additionally estimated with the two subtests matrix reasoning and similarities from the Wechsler Intelligence Scale for Children - fifth edition (WISC-V) or Wechsler Adult Intelligence Scale - fourth edition (WAIS-IV).\n2. Comorbid psychotic disorder, bipolar disorder, severe eating disorder, severe depression, alcohol\u002Fsubstance dependence or hoarding disorder. Confirmed by the caregiver at the telephone screening and subsequently by the assessor at the inclusion assessment based on the structured diagnostic interview and, if required, the medical record.\n3. Current suicidal intent or a previous suicide attempt within the last 12 months. Confirmed by the assessor at the inclusion assessment and, if required, the medical record.\n4. Main symptom presentation consists of hoarding symptoms. Confirmed by the assessor at the inclusion assessment.\n5. Completed CBT for OCD within the last 12 months prior to the inclusion assessment (defined as at least 5 sessions of CBT including ERP). Confirmed by the caregiver at the telephone screening or\u002Fand inclusion assessment and, if required, the medical record.\n6. Simultaneous psychological treatment for OCD or anxiety. Confirmed by the caregiver at the telephone screening and\u002For inclusion assessment.\n7. Initiation, dosage change or cessation of medication for OCD (primarily selective serotonin reuptake inhibitors, SSRIs) or behavioural symptoms of ASD (atypical antipsychotics) within the 6 weeks prior to the baseline assessment. Confirmed by the caregiver at the telephone screening and the inclusion assessment and, if required, the medical record.\n8. Having a close relationship to an already included participant (e.g., sibling, cousin), to avoid being randomised into two different arms, with the risk of information \"leaking\" between the groups. Confirmed by the caregiver or assessor at the telephone screening and\u002For at the inclusion assessment.","ALL","7 Years","17 Years",{"count":125,"type":126},220,"ESTIMATED","INTERVENTIONAL",[129],"NA","The purpose of this trial is to evaluate the clinical efficacy, the cost-effectiveness and the effect durability of a therapist-guided, internet-delivered cognitive-behavior therapy intervention for obsessive-compulsive disorder (OCD) in children and adolescents with autism. A process evaluation of the treatment will also be conducted.",[132,133],"Obsessive-Compulsive Disorder","Autism Spectrum Disorder",[132,133,135,136,137,138,139],"Exposure and Response Prevention","Cognitive-Behavioural Treatment","Internet","Guided self-help","Stress Management","2026-05-05",{"date":142,"type":143},"2026-05-08","ACTUAL",{"date":145,"type":143},"2024-11-25",{"date":147,"type":126},"2027-12",{"name":5,"class":6},3]